NCT07471776

Study on Using TROP2-PET and 18F-FDG PET to Predict the Efficacy of Anti TROP2 ADC Treatment in Advanced Breast Cancer

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study aims to evaluate whether \^68Ga-TROP2 PET/CT, combined with \^18F-FDG PET/CT, can predict the efficacy of anti-TROP2 antibody-drug conjugates in patients with advanced HER2-negative breast cancer. Baseline and dynamic imaging parameters will be used to develop prediction models (primary endpoint: AUC), and their associations with clinical outcomes and tumor TROP2 status will be explored.

Conditions

• Metastatic Breast Cancer ( HER2 Negative)

Interventions

Type	Name	Description
DRUG	Sacituzumab Govitecan、Datopotamab deruxtecan、Sacituzumab tirumotecan	TROP2-targeted antibody-drug conjugate administered according to standard clinical dosing schedule until disease progression or unacceptable toxicity.
DIAGNOSTIC_TEST	68Ga-TROP2 PET/CT Imaging	Whole-body PET imaging using 68Ga-labeled TROP2-targeting tracer to assess in vivo TROP2 expression prior to TROP2 ADC treatment initiation.
DIAGNOSTIC_TEST	18F-FDG PET Imaging	Standard 18F-FDG PET imaging performed prior to TROP2 ADC treatment to assess tumor metabolic activity.

Timeline

• Start date: 2026-03-11
• Primary completion: 2028-03-11
• Completion: 2029-03-11
• First posted: 2026-03-13
• Last updated: 2026-03-13

Locations

2 sites across 1 country: China